Blue Ortho FDA Record
- Latest inspection NAI · Apr 11, 2024
- No warning letters matched by name
Blue Ortho has 3 FDA recalls, 2 inspections, 10 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Blue Ortho" is on file.
- Latest recall
- Z-0209-2025 · Class II · Aug 30, 2024
- Latest inspection
- Apr 11, 2024 · NAI
- Latest 510(k)
- Oct 26, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 3 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 10 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Blue Ortho: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 1 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 1 | 0 |
| 2019 | 0 | 0 | 0 | 1 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0209-2025 | Class II | Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide… | Aug 30, 2024 |
| Z-0288-2021 | Class II | Instructions For Use document of the GPS Trackers. | Sep 10, 2020 |
| Z-1149-2020 | Class II | Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic… | Sep 22, 2019 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 11, 2024 | Meylan, France | Devices | No Action Indicated (NAI) | 3008027912 |
| Dec 17, 2015 | Meylan, France | Devices | Voluntary Action Indicated (VAI) | 3008027912 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008027912 | Meylan, France | 2 | Apr 11, 2024 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K262567 | GPS Ankle | Oct 26, 2026 |
| K233299 | ExactechGPS® System | Jan 26, 2024 |
| K232521 | ExactechGPS® Total Ankle Application | Nov 16, 2023 |
| K213877 | ExactechGPS® System | May 2, 2022 |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Jan 6, 2022 |
| K193618 | ExactechGPS System | Sep 2, 2020 |
| K173372 | ExactechGPS Total Shoulder Application | Nov 24, 2017 |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Apr 5, 2017 |
| K152764 | EXACTECH GPS | Jul 13, 2016 |
| K100742 | EXACTECH GPS | Oct 21, 2010 |
Blue Ortho and the FDA: common questions
Has Blue Ortho received an FDA warning letter?
No FDA warning letter addressed to the name "Blue Ortho" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Blue Ortho received an FDA Form 483?
FDA has not published a Form 483 for "Blue Ortho" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Blue Ortho?
The most recent FDA inspection on file ended Apr 11, 2024 at Meylan, France and was classified NAI. FDA has 2 inspections of Blue Ortho on file.
Has Blue Ortho had an FDA recall?
Yes. Blue Ortho has 3 FDA recalls on record. The most recent started Aug 30, 2024.
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